MAUDE Adverse Event Report: MEDTRONIC, INC PWP CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 150075

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A pwp catheter was attempted to be used during a rhc procedure for implant of a non-medtronic device.It was reported that movement of the pwp device caused a heart block.The patient received atropine and the issue resolved without any further intervention.The procedure was successfully completed with no adverse patient consequences.

• Brand Name: PWP CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 10605550
• MDR Text Key: 209136052
• Report Number: 1220452-2020-00078
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00613994733658
• UDI-Public: 00613994733658
• Combination Product (y/n): N
• PMA/PMN Number: K884065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2022
• Device Model Number: 150075
• Device Catalogue Number: 150075
• Device Lot Number: 0010082305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Date Device Manufactured: 01/07/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other